# US 10,869,708 B2 · Anisotropic biocomposite material, medical implants comprising same and methods of treatment thereof

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- Number: US 10,869,708 B2
- Document ID: US10869708B2
- Status: Granted
- Kind: B2
- Application number: 15/509,301
- Filed: 2015-09-07
- Published: 2017-08-31
- Granted: 2020-12-22
- Earliest claimed: 2014-09-07
- Assignees: Ossio, Ltd.
- Applicants: Ossio Ltd
- Inventors: Orahn Preiss-Bloom; Taly Pnina Lindner
- Web page: https://patentgrep.com/patent/US10869708B2

## CPC

- A61B 17/8875: {Screwdrivers, spanners or wrenches}
- A61B 17/16: Instruments for performing osteoclasis; Drills or chisels for bones; Trepans {(arthroscopic bone cutters A61B17/320016)}
- A61B 17/1615: {Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material}
- A61B 17/1617: {with mobile or detachable parts}
- A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates}
- A61B 17/8625: {Shanks, i.e. parts contacting bone tissue}
- A61B 17/863: {with thread interrupted or changing its form along shank, other than constant taper}
- A61B 17/8635: {Tips of screws}
- A61B 17/864: {hollow, e.g. with socket or cannulated}
- A61B 17/866: {Material or manufacture}
- A61F 2/30965: {Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping}
- A61L 27/365: {Bones}
- A61L 27/446: {with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46}
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- A61L 31/128: {containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- A61B 17/064: Surgical staples, {i.e. penetrating the tissue}
- A61B 17/12009: {Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot}
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00964: {composite}
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Reinforced biocomposite materials. According to at least some embodiments, medical implants are provided that incorporate novel structures, alignments, orientations and forms comprised of such reinforced bioabsorbable materials, as well as methods of treatment thereof.

## Claims

### Claim 1

An orthopedic fixation implant comprising absorbable structural material, wherein strength and stiffness properties are anisotropic; the absorbable structural material comprising a reinforcement filler, wherein said absorbable structural material further comprises a biodegradable polymer; wherein an average density of the absorbable structural material is in a range of 1.3-3.0 g/cm3; wherein said reinforcing filler comprises a plurality of reinforcing fibers and wherein a weight ratio of reinforcing fibers to said biodegradable polymer is in the range of 1:1 to 1:3; and wherein a percentage of reinforcing fibers is in the range of 40% to 50% weight per weight; wherein a plurality of said reinforcement fibers are arranged in parallel to a longitudinal axis of the implant.

### Claim 2 (depends on 1)

The implant of claim 1, wherein the biodegradable composite has a maximum flexural modulus in the range of 6 GPa to 30 GPa and flexural strength in the range of 100 MPa to 1000 MPa.

### Claim 3 (depends on 1)

The implant of claim 1, having improved mechanical properties in at least one mechanical axis or parameter as compared with at least one other mechanical axis or parameter within the same implant, such that the implant is anisotropic; wherein said mechanical parameter comprises one or more of bending strength and stiffness (resistance to bending force), tensile strength and stiffness (resistance to tensile force), compression strength and stiffness (resistance to compression force), shearing strength and stiffness (resistance to shearing force), or torsional strength and stiffness (resistance to torsional force); where in properties are anisotropic of at least 10%, at least 20%, at least 30%, 40%, 50%, 60%, 70%, 80%, 90% or 100%, or any number in between.

### Claim 4 (depends on 1)

The implant of claim 1, wherein said biodegradable polymer comprises a homopolymer or a copolymer; wherein said copolymer comprises a random copolymer, block copolymer, or graft copolymer; and wherein said biodegradable polymer comprises a linear polymer, a branched polymer, or a dendrimer, of natural or synthetic origin;
wherein said biodegradable polymer comprises lactide, glycolide, caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate), dioxanones (e.g., 1,4-dioxanone), δ-valerolactone, 1, dioxepanones (e.g., 1,4-dioxepan-2-one and 1,5-dioxepan-2-one), ethylene glycol, ethylene oxide, esteramides, y-hydroxyvalerate, β-hydroxypropionate, alpha-hydroxy acid, hydroxybutyrates, poly (ortho esters), hydroxy alkanoates, tyrosine carbonates, polyimide carbonates, polyimino carbonates, such as poly (bisphenol A-iminocarbonate) and poly (hydroquinone-iminocarbonate), polyurethanes, polyanhydrides, polymer drugs (e.g., polydiflunisol, poly aspirin, and protein therapeutics), sugars; starch, cellulose and cellulose derivatives, polysaccharides, collagen, chitosan, fibrin, hyaluronic acid, polypeptides, proteins, poly (amino acids), polylactides (PLA), poly-L-lactide (PLLA), poly-DL-lactide (PDLLA); polyglycolide (PGA); copolymers of glycolide, glycolide/trimethylene carbonate copolymers (PGA/TMC); other copolymers of PLA, such as lactide/tetramethylglycolide copolymers, lactide/trimethylene carbonate copolymers, lactide/d-valerolactone copolymers, lactide/ε-caprolactone copolymers, L-lactide/DL-lactide copolymers, glycolide/L-lactide copolymers (PGA/PLLA), polylactide-co-glycolide; terpolymers of PLA, such as lactide/glycolide/trimethylene carbonate terpolymers, lactide/glycolide/ε-caprolactone terpolymers, PLA/polyethylene oxide copolymers; polydepsipeptides; unsymmetrically- 3,6-substituted poly-1,4-dioxane-2,5-diones; polyhydroxyalkanoates, such as polyhydroxybutyrates) PHB); PHB/b-hydroxyvalerate copolymers (PHB/PHV); poly-b-hydroxypropionate (PHPA);
poly-p-dioxanone (PDS); poly-d-valerolactone-poly-ε-capralactone, poly(ε-caprolactone-DL-lactide) copolymers; methylmethacrylate-N-vinyl pyrrolidone copolymers; polyesteramides;
polyesters of oxalic acid; polydihydropyrans; polyalkyl-2-cyanoacrylates; polyurethanes (PU);
polyvinylalcohol (PVA); polypeptides; poly-b-malic acid (PMLA): poly-b-alkanoic acids;
polycarbonates; polyorthoesters; polyphosphates; poly(ester anhydrides); and derivatives, copolymers and mixtures thereof.

### Claim 5 (depends on 1)

The implant of claim 1, wherein the polymer is in a form of a polymer matrix; wherein said polymer matrix comprises a polymer selected from the group consisting of PLLA (poly-L-lactide), PDLLA (poly-DL-lactide), PLDLA, PGA (poly-glycolic acid), PLGA (poly-lactide-glycolic acid), PCL (polycaprolactone), PLLA-PCL and a combination thereof.

### Claim 6 (depends on 5)

The implant of claim 5, wherein an inherent viscosity (IV) of the polymer matrix alone is in the range of 0.2-6 dl/g, 1.0 to 3.0 dl/g, 1.5 to 2.4 dl/g, or 1.6 to 2.0 dl/g, wherein IV is measured according to a flow time of a polymer solution through a narrow capillary relative to the flow time of a pure solvent through the capillary.

### Claim 7 (depends on 1)

The implant of claim 1, wherein if PLLA is used, the matrix comprises at least 30% 50%, or at least 70% PLLA; or wherein if PDLA is used, the matrix comprises at least 5%, at least 10%, or at least 20% PDLA.

### Claim 8 (depends on 1)

The implant of claim 1, wherein said weight ratio is in a range of 0.75:1 to 1.25:1.

### Claim 9 (depends on 8)

The implant of claim 8, wherein said fibers comprise one or more of a biodegradable glass or glass-like materials, a ceramic, a mineral composition (optionally including one or more of hydroxyapatite, tricalcium phosphate, calcium sulfate, calcium phosphate), a cellulosic material, a nano-diamond, or any other filler known in the art to increase the mechanical properties of a bioabsorbable polymer, or wherein said fiber comprises a bioabsorbable glass, ceramic, or mineral composition.

### Claim 10 (depends on 9)

The implant of claim 9, wherein said biodegradable glass has oxide compositions in the following mol. % ranges (as a percent over the glass fiber composition):
Na2O: 11.0-19.0 mol. %,
CaO: 9.0-14.0 mol. %,
MgO: 1.5-8.0 mol. %,
B2O3: 0.5-3.0 mol. %,
Al2O3: 0-0.8 mol. %,
P2O3: 0.1-0.8 mol. %,
SiO2: 67-73 mol. %.

### Claim 11 (depends on 10)

The implant of claim 10 where said ranges are the following mol. % ranges:
Na2O: 12.0-13.0 mol. %,
CaO: 9.0-10.0 mol. %,
MgO: 7.0-8.0 mol. %,
B2O3: 1.4-2.0 mol. %,
P2O3: 0.5-0.8 mol. %,
SiO2: 68-70 mol. %.

### Claim 12 (depends on 1)

The implant of claim 1, wherein an average fiber diameter is between 5 and 50 um.

### Claim 13 (depends on 12)

The implant of claim 12, wherein a tensile strength of the reinforcement fiber is in the range of 1200-2800 MPa, or wherein an elastic modulus of the reinforcement fiber is in the range of 30-100 GPa, or a combination thereof.

### Claim 14 (depends on 1)

The implant of claim 1 wherein at least 50% of elastic modulus is retained following exposure to simulated body fluid (SBF) at 50 C for 3 days, or at least 70% is retained, and even at least 80% is retained.

### Claim 15 (depends on 1)

The implant of claim 1 wherein implant is an orthopedic implant and is selected from the groups including bone fixation plates, intramedullary nails, joint (hip, knee, elbow) implants, spine implants, screws, pins, wires, soft tissue anchors and other devices for such applications such as for fracture fixation, tendon reattachment, spinal fixation, and spinal cages.

### Claim 16 (depends on 1)

The implant of claim 1 wherein a reinforcing fiber diameter is in a range of 2-40 um, 8-20 um, or 12-18 um (microns).

### Claim 17 (depends on 1)

The implant of claim 1, wherein the orthopedic fixation implant is a pin, plate, screw, nail, fiber, sheet, rod, staple, clip, needle, tube, anchor, cable, tie, or wire tie.

### Claim 18 (depends on 17)

The implant of claim 17, wherein the implant is a pin, screw, plate, nail, rod, staple, or wire.